LEAPS-NCHD Program Evaluation
NCT03764436, Not applicable, Completed, Harvard School of Public Health (HSPH)
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | LEAPS-NCHD Program Evaluation | ClinicalTrials.gov |
| NCT number | NCT03764436 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 3,858 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Harvard School of Public Health (HSPH) | ClinicalTrials.gov |
| Conditions | Child Development | ClinicalTrials.gov |
| Interventions | LEAPS-NCHD Program | ClinicalTrials.gov |
| First posted | 2018-12-05 | ClinicalTrials.gov |
| Last updated | 2021-08-09 | ClinicalTrials.gov |
Registered outcomes 13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | School readiness | Up to 31 months | School readiness of children aged 54 - 66 months assessed using the International Development \& Early Learning Assessment (IDELA). IDELA includes domains for emergent math (7 items), socio-emotional development (5 items), self-regulation (1 item), emergent literacy (6 items), fine motor skills (3 items), and gross motor skills (1 item). Total scores are calculated for each domain, and a total IDELA score for school readiness is generated from the domain scores. Higher scores reflect better outcomes. | ClinicalTrials.gov |
| Secondary | Child executive functioning skills: working memory | Up to 31 months | Direct assessment examining working memory capacity among children aged 54 - 66 months using the Corsi Block-tapping Test (Noel, 2009). The child's score reflects the longest sequence for which two block series were repeated correctly, plus 0.5 if one longer series was also correctly processed (range: 0 - 4 points). Higher scores indicate better outcomes. | ClinicalTrials.gov |
| Secondary | Child general executive functioning skills | Up to 31 months | The Head Toes Knees Shoulders task (Ponitz et al., 2008) will be used to assess general executive functioning skills among children aged 54 - 66 months. The assessment contains two sections, part one being easier and part two more challenging. Child participants may receive 0 to 20 points for each section. Scores will be presented separately for each section. Higher scores reflect better outcomes. | ClinicalTrials.gov |
| Secondary | Child executive functioning skills: inhibitory control | Up to 31 months | Direct assessment examining inhibitory control skills among children aged 54 - 66 months using the Knock and Tap assessment (Molfese et al., 2010). Total score is the sum across 16 items (range: 0-16 points). Higher scores reflect better outcomes. | ClinicalTrials.gov |
| Secondary | Child executive functioning skills: inhibitory control | Up to 31 months | Direct assessment examining inhibitory control skills among children aged 54 - 66 months using the Peg Tap assessment (range: 0-16 points) (Molfese et al., 2010). Total score is the sum across 16 items. Higher scores reflect better outcomes. | ClinicalTrials.gov |
| Secondary | Child executive functioning skills: cognitive flexibility | Up to 31 months | Direct assessment of cognitive flexibility skills among children aged 54 - 66 months, using the Dimensional Change Card Sort (DCCS) (Carlson, 2005). Participants are requested to sort cards at 3 levels. In the "separated" level, the cards depict a black silhouette shape (e.g., rabbit or boat) on a colored card. Thus, the shape and color dimensions are separated. In the "integrated" level, the shape and color are integrated on the card (i.e., red rabbit and blue boat). During "switch trials," participants must change the dimension being matched. In the "border" level, the integrated pictures from the previous level are used, but half of the cards have borders. Five subscores will be examined: Total number correct trials on the separated level, pre- and post-switch (0-6 points each); total number correct trials on the integrated level, pre- and post-switch (0-6 points each); and total correct on the border version (0-12 points). Higher scores reflect better outcomes. | ClinicalTrials.gov |
| Secondary | Youth executive functioning skills: working memory | Up to 31 months | Direct assessment to examine working memory skills of youth using the Backward Word Span task (Davis et al., 1995). The participant's score reflects the longest sequence for which two series were repeated correctly, plus 0.5 if one longer series was also correctly processed (range: 0 - 6 points). Higher scores reflect better outcomes. | ClinicalTrials.gov |
| Secondary | Youth executive functioning skills: working memory | Up to 31 months | Direct assessment to examine working memory capacity of youth using the Corsi Block-tapping Test (Kessels et al., 2000). Participants will be administered two tests: a forward and a backward test. A score will be awarded for each test, reflecting the longest sequence for which two series were repeated correctly, plus 0.5 if one longer series was also correctly processed (range for each: 0 - 7 points). Higher scores reflect better outcomes | ClinicalTrials.gov |
| Secondary | Youth executive functioning skills: inhibitory control | Up to 31 months | Direct assessment to examine inhibitory control skills of youth using the Number Stroop Effect (Stroop, 1935). Points are summed across 20 items to calculate the overall sum score (range: 0-20 points). Higher scores reflect better outcomes. | ClinicalTrials.gov |
| Secondary | Youth executive functioning skills: cognitive flexibility | Up to 31 months | Direct assessment to examine cognitive flexibility skills of youth using the Trail Making Task (TMT) (Lezak, 1995; Reitan \& Wolfson, 1993). Scores reflect the time for completion in seconds, with the maximum time limit being 300 seconds (range: 0-300). Lower scores indicate a better outcome. | ClinicalTrials.gov |
| Secondary | Youth personal and professional development | Up to 31 months | Self-reported questionnaire developed for study context which includes items examining aspects of professional and personal development pertaining to autonomy, self-efficacy, self-esteem, professional growth and aspirations. This does not include a standardized scale. | ClinicalTrials.gov |
| Secondary | Youth self-reported depressive symptoms | Up to 31 months | Youth self-reported depressive symptoms using the Self Reporting Questionnaire 20-item (SRQ-20). Items are summed for a total score of depressive symptoms over the last 30 days (range: 0 - 20 points). Higher scores reflect poor outcomes. | ClinicalTrials.gov |
| Secondary | Classroom structural and process quality | Assessed after program has been running for a minimum of 2 months | Classroom quality assessed using the Measure of Early Learning Environments (MELE) module of the Measuring Early Learning Quality and Outcomes (MELQO) tool. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 4
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 7
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Corsi Block-Tapping Test | Secondary outcome | ConductCognition |
| Dimensional Change Card Sort | Secondary outcome | ConductCognition |
| Numerical Stroop Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Word Span Task | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)